RELATED APPLICATION INFORMATION
This application claims priority from Indian provisional Patent Application No. 16/DEL/2011 filed on January 4, 2011. The entire content of which is incorporated herein by this reference. The applicants claim the benefit of this provisional application.
FIELD OF THE INVENTION
This invention generally relates to an administration set of the type used for fluid delivery to a patient. More particularly, the invention relates to a fluid administration set including a burette having an automatic shut off valve for controlling the flow of fluid wherein the fluid administration set is connected between an IV fluid source and a patient.
BACKGROUND OF THE INVENTION
Fluid administration sets including burettes with drip chambers are widely used for administering medical fluids and/or medication to a patient. The burettes typically include a burette chamber with a primary liquid inlet to the chamber and also an injection site communicating with the chamber for injecting medicament into the chamber so that, for example, the medicament may be diluted with the primary liquid.
During the administration of medical fluids to a patient, it is important that amounts of air exceeding a certain threshold not be infused. If too large a quantity of air is allowed to enter the patient's blood stream, an embolism could result, which can be a serious condition.
There are various known devices having shut off valves that have been incorporated directly into the drip chamber device to automatically shut off fluid flow through the fluid line once the medical fluid reservoir has emptied.

Problems have arisen with such devices, one of which is that the under adverse conditions, such as where the administration set may be moving from side to side or oriented at an angle other than directly vertical, the valve device may be slow in seating and fluid shut off may be delayed, thus raising the possibility that air may enter the administration line.
Further, using the burette set now commercially available, it is necessary for health care workers to personally be present to adjust the burette for drug or medicament administration and then personally be present after medicament administration to readjust the burette chamber to its other operative position and thereby restart the flow of the IV solution being administered.
The fluid administration set of this invention eliminates the need for the personal attention of the health care worker to reinitiate IV flow after medicament administration. It also provides a closed, airtight chamber for the mixing of medicaments.
Further the fluid administration set of this invention provides a disposable administration set including a reliable automatic fluid flow shut off device that provides an effective seal to prevent the passage of air. In addition, a device of this nature is cost effective and easy to manufacture. Thus, the present invention meets these needs and others.
SUMMARY OF THE INVENTION
As embodied and broadly described, in accordance with the present invention, A fluid administration set for controlling the flow of fluid, the fluid administration set connected between an IV fluid source and a patient, the said fluid administration set comprising: a spike connector for coupling to the said IV fluid source; an inlet tube member coupled to said spike connector connected to the main inlet of a burette defining a chamber; the said chamber connected in line with the said tube member to accumulate medical fluid; the said chamber comprising: an upper end

forming a top cap having an inlet port; a lower end forming a bottom cap having an outlet port; a side wall connecting and disposed between the said upper end and to the said lower end; a valve seat mounted in the lower end at the outlet port projecting into the said chamber, the said outlet port connected to a drip chamber extending from the bottom thereof and in series with the flow line, the said drip chamber comprising: an elongated transparent hollow housing defining an inlet at one end thereof and an outlet at the other end, fluid filter member positioned adjacent the said outlet, said fluid filter member defining a pore size sufficient to permit the passage of liquid and to prevent the passage of air, when wetted, under normal conditions of use, the said outlet connected to an outlet tube; and a shut-off valve located in the said burette chamber, the said valve formed such that it floats in the medical fluid accumulated in the said burette chamber, the floating disk member comprising: an upper surface, a lower surface, and a predetermined amount of buoyancy, the shut-off valve adapted to provide fluid passing from the inlet into the drip chamber while permitting the passage of fluid from the upper surface of the shut-off valve to the lower surface of the shut off-valve; and the said valve being configured to be accommodated and provided support onto the said seat when there is less than a predetermined amount of fluid in the burette chamber, the said valve and the said seat forming an air tight seal between the burette chamber and the outlet of the burette to prevent the passage of air into the outlet of the burette when there is less than a predetermined amount of fluid in the burette chamber; the said seat being configured as such to allow the buoyancy of the said valve to cause separation between the valve and the seat when there is more than a predetermined amount of fluid in the burette chamber to allow the fluid to flow from the burette chamber into the outlet of the burette and through the said burette chamber to the patient.
BRIEF DESCRIPTION OF THE DRAWINGS:
FIG. 1 is a front view of a fluid administration set constructed in accordance with the principles of the present invention;

FIG. 2A is an exploded, cross-sectional side view of the shut-off valve according to an illustrated embodiment of the present invention;
FIG. 2B is a cross-sectional side view of the shut-off according to an illustrated embodiment of the present invention;
FIG 3A and 3B is a cross-sectional side view of the lower end forming the bottom cap of the burette showing the drainage line according to an illustrated embodiment of the present invention;
FIG. 4A is a cross-sectional front view of the assembly illustrating the drip chamber and burette chamber showing the shut-off valve in the suspended position according to an illustrated embodiment of the present invention;
FIG 4B is a cross-sectional front view of the assembly showing the drip chamber according to an illustrated embodiment of the present invention;
DETAILED DESCRIPTION OF THE INVENTION
While this invention is susceptible of embodiment in many different forms, there will be described herein specific embodiments thereof with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the embodiments detailed herein.
In the illustrated embodiment, the burette 22 includes a drip chamber 50, an outlet 20, and an inlet 18. Drip chamber 50 is configured to hold a volume of medical fluid. According to the preferred embodiment of the present invention, the burette 22 wall 26 and the drip chamber 50 wall 26 is comprised of a transparent or semi-transparent material which allows the user to view the level of medical liquid media in the burette 22 and the drip chamber 50.

Referring to FIG. 1, the fluid from the bag or IV solution source flow through the upstream main liquid inlet tube member 14 and into the burette 22 having an top cap 64 and a bottom cap 66 where it is accumulated to the desired level. The inlet 18 provided in the inlet port 32 of the burette 22 is then closed and the fluid allowed to exit through the outlet port 34 of the burette 22 into the drip chamber 50. The drop former forms precisely-sized drops that may be counted and timed to verify that a desired flow rate has been established with a variable clamp or other means. Because the fluid level in the transparent container is high, the automatic shut off valve 36 is above the valve seat 44 and fluid flows out the burette chamber 24 through the exit orifice/drainage line 46 configured in the bottom cap 66 of the burette 22 and through the drip chamber 50 and to the downstream outlet tube member/line 16 flowing into the patient. As the fluid in the drip chamber 50 is depleted, the surface level thereof descends and shut off valve 36 comes in its closed condition. In such state, the shut off valve 36 comes in sealing engagement with the valve seat 44 to close the outlet port 34 to stop the passage of air therethrough.
The administration set 10 includes flexible tube members formed of a suitable material such as plastic or soft and kink resistant PVC tube member. It is preferable that the side wall 26 of the burette 22 be formed of a flexible plastic material and that it is substantially transparent. The spike 12 used in the invention may be air vented or non vented spike 12.
Thus, the fluid administration set 10 of the present invention is provided with a spike connector 12 for coupling to a IV solution source (not shown), an inlet tube member 14 connected to main liquid inlet 18 of a burette 22 having calibrated measured volume chamber 24 with bold marking scale 74, the burette 22 having a drip chamber 50 extending from the bottom thereof and in series with the flow line, an outlet tube member 16 connected from drip chamber 50 to an injection site having a self sealing "Y" injection port 56, the outlet tube member 16 being provided with a roller clamp 58 and tube member connected from the outlet 20 of injection site 56 to a conventional needle adapter 78.

The automatic shut off valve 36 is positioned in the burette 22. The automatic shut off valve 36 prevents air tapping in the fluid line once the measured volume chamber 24 of the burette 22 is empty and it also indicates the level of liquid. The automatic shut off valve 36 includes a predetermined amount of buoyancy which positions it above the surface of the volume of the medical fluid. Thus, the automatic shut-off valve 36 provides an impact surface for the droplets of the medical fluid falling from inlet 18 of the burette 22. As the droplets of medical fluid strike the valve 36, the velocity of the droplets is substantially reduced. The droplets can then flow along the upper surface 60 of automatic shut off valve 36 and into the volume being stored at the lower end 30 of the burette 22. In the illustrated embodiment, the diameter of automatic shut off valve 36 is sufficiently smaller than the diameter of the burette chamber 24 to allow unobstructed flow of medical fluid media from the upper surface 60 of the valve 36 into the volume being stored at the lower end 30 of the burette 22. Additionally, the droplets being striking the automatic shut off valve 36 minimizes the entrapment of air in the chamber 24 of the burette 22 that could otherwise be released into the outlet 20 of burette 22 and eventually into the outlet line 16.
The volume being stored at the lower end 30 of the burette 22 flows through a drainage line 46 configured into the seat assembly 76 at the lower end 30 of the burette 22, forming an outlet 20 and into the drip chamber 50, through its inlet line 14. Thereafter, the fluid flows from the outlet 20 of the drip chamber 50 into outlet line 16 which can be infused into the patient.
When the volume of medical fluid is exhausted in the IV fluid source, medical fluid no longer flows into drip chamber 50 from inlet 18. Thus, when the IV fluid source is no longer filling drip chamber 50, as long as the volume medical fluid continues to flow into outlet line 16, the level of the volume of medical fluid being stored in the lower end 30 of the burette 22 will begin to lower. As the level of the volume of medical fluid begins to lower, the positioning of automatic shut off valve 36 also

begins to lower. In this manner, the automatic shut off valve 36 can be utilized as an indicator of the level of the volume of medical fluid in the burette chamber 24.
The lowering of automatic shut off valve 36 signals to the medical practitioner/attendant that the source of medical fluid is exhausted and needs to be replaced. In such a situation volume of medical fluid in drip chamber 50 maintains the flow of medical fluid to the patient even where the fluid source is exhausted and fluid is no longer filling burette 22. This provides the practitioner/attendant with time to replace the IV fluid source after the medical fluid is no longer flowing into burette 22.
When the volume of medical fluid in burette chamber 24 is substantially emptied from burette chamber 24, the automatic shut off valve 36 contacts and is supported by seat assembly 76 configured at the lower end 30 of the burette 22. The configuration of the lower surface 62 of automatic shut off valve 36 conforms to the configuration of the upper surface 60 of seat assembly 76 such that seat assembly 76 accommodates and provides a desired positioning of automatic shut off valve 36 onto the seat assembly 76. In the illustrated embodiment, the automatic shut off valve 36 constitutes an upper ring 38 and an inner'ring 40. The upper ring 38 forms the upper surface 60 of the automatic shut off valve 36. The upper ring 38 comprises at least two projections 70 at its lower surface 62. The inner ring 40 of the automatic shut off valve 36 likewise comprises at least two projections 70 at its lower surface 62 which gets accommodated in the upper surface 60 of the automatic shut off valve 36. Thus, the automatic shut off valve 36 is configured to provide an air tight seal with the drainage line 46 of the seat assembly 76 when it lowers onto the seat assembly 76.
A filter member 68 is provided at the upper end 28 forming the bottom cap 66 of the burette chamber 24. The filter member 68 is provided for filtering any air which passes into the burette chamber 24. As is well known to those skilled in the art, the hydrophobic filter is a filter which permits the passage of air but which prevents the passage of liquid in either direction. It is formed of a suitable material

such as a two micron pore size bacterial filter. The pore size of the material is such that it will only permit bacteria free air to enter into the burette chamber 24 via bacteria retentive air inlet. Further, the fluid administration set 10 of the invention includes means for filtering out the particulate matter.
FIG. 2A is a close-up front view showing the body 42 of the automatic shut off valve 36 and its upper 38 and inner 40 rings. In the illustrated embodiment, both rings 38, 40 being provided with an outer circumferential rim and at least two projections 70 configured at the lower surfaces 62 of the said rings 38, 40.
In the illustrated embodiment, the degree of curvature of upper ring 38 and inner ring 40 and the outer circumferential rim of the automatic shut off valve 36 results in a disk-like configuration of automatic shut off valve 36 as shown in FIG. 2B. Further, the outer circumferential rim provides a mechanism for coupling inner ring 40 and upper ring 38 together with the body 42 of the automatic shut off valve 36.
The disk-like configuration of automatic shut off valve 36 minimizes flipping of the valve 36. The surface area and degree of curvature of the upper 38 and inner 40 rings increases the buoyancy of automatic shut off valve 36 relative to the overall volume of automatic shut off valve 36.
As will be appreciated by those skilled in the art, the automatic shut off valve 36 can be constructed utilizing a number of materials without departing from the scope and spirit of the present invention. For example, in one embodiment the automatic shut off valve 36 is constructed from a soft and pliable material such as silicone or suitable plastic material. In another embodiment, the automatic shut off valve 36 is constructed from a material having a desired amount of buoyancy either alone, or in combination with air pockets, or in combination with other buoyant materials. Additionally, the seat 44 can be adapted to have soft and pliable properties to accommodate automatic shut off valves 36 having more rigid material properties.

Further, as will be appreciated by those skilled in the art, the present invention encompasses a variety of types and configurations of automatic shut off valve 36 which can be utilized without departing from the scope and spirit of the present invention.
In the illustrated embodiment, lower end 30 forming the seat assembly 76 of the burette 22 includes a drainage line 46 and a seat 44 as shown in FIG. 3A and 3B. Drainage line 46 provides a drip line for the volume of medical liquid flowing from the burette chamber 24 into drip chamber 50. Drainage line 46 is positioned in fluid communication with the outlet 20 of burette 22. Drainage line 46 is positioned substantially at the center of seat assembly 76. Drainage line 46 includes a bore 48 extending to the entire length of the drainage line 46 from the bottom of the burette 22 and is provided with a circumferential contact surface being configured to provide an airtight seal when positioned in contact with the automatic shut off valve 36.
Seat 44 is configured to accommodate the lower surface 62 of the automatic shut off valve 36. In the illustrated embodiment, the lower surface 62 of the automatic shut off valve 36 includes plurality of projections (not shown). The plurality of projections provides a desired amount of displacement between the bottom of the burette 22 and the lower surface 62 of the automatic shut off valve 36. Additionally, projections properly position automatic shut off valve 36 relative to the circumferential contact surface to provide an air tight seal between the automatic shut off valve 36 and circumferential contact surface.
The configuration of projections allows the medical fluid to flow between projections and into contact with lower surface 62 of the automatic shut off valve 36. As a result, where the medical fluid begins to fill the chamber 24 of the burette 22, the fluid contacts and provides a buoyant force on lower surface 62 of the automatic shut off valve 36. When the level of the fluid media is raised sufficiently, the amount of buoyancy of the automatic shut off valve 36 exceeds any vacuum effect between lower surface 62 and circumferential contact surface. As a result,

lower surface 62 separates from circumferential contact surface and the flow of fluid through drainage line 46 to the outlet 20 of the burette 22 can resume. Thus when the volume of the medical fluid continues to increase, the buoyancy of the automatic shut off valve 36 overcomes any vacuum effect maintaining the contact between the valve 36 and seat assembly 76. As a result, the automatic shut off valve 36 separates from seat assembly 76 resuming the flow of the medical liquid from drainage line 46 through outlet 20 into drip chamber 50 and through outlet tube member/line 16 into the patient.
The vacuum effect in outlet 20 and outlet line 16 prevents additional flow of the remaining volume of the medical fluid from outlet line 16 to the patient. This prevents migration of air into outlet line 16 when the volume of the medical fluid in drip chamber 50 of the burette 22 is exhausted. By preventing migration of air into outlet line 16, the practitioner need not remove air that would otherwise form in outlet line 16 the volume of medical fluid in drip chamber 50 is returned to normal levels.
As will be appreciated by those skilled in the art, a variety of types and configurations of seat 44 assemblies can be utilized without departing from the scope and spirit of the present invention. For example, a variety of types, numbers, and configurations of projections of the automatic shut off valve 36 can be utilized.
As shown in FIG. 4A and 4B, a drip chamber 50 of the burette 22 is configured for fluid communication with an outlet 20 connection of the burette 22. The drip chamber 50 of the fluid administration set 10 comprises an elongated, tubular housing 52 and an bottom cap 66. Together, housing 52 and bottom cap 66 define an interior houisng for receiving and collecting fluids. Drip chamber 50 further comprises a fluid filter member 54. The housing 52 of the drip chamber 50 has a generally elongated, tubular shape. In the presently preferred embodiment, housing 52 has a first portion of substantially uniform diameter, an intermediate cylindrical portion having a slightly reduced diameter, a conically shaped portion

and an outlet 20 member. Outlet 20 member is configured to receive the proximal end of outlet line 16 in mating relationship. The proximal end of outlet line 16 is permanently and securely fastened outlet 20 member through the use of a suitable adhesive or other suitable sealing means. The precise dimensions of housing 52 depend on the desired volume, as well as the desired medical application for which the drip chamber 50 is to be utilized.
In the illustrated embodiment, the fluid flows from the IV fluid source, such as a bag or bottle, into inlet line 16. From inlet line 16 the fluid flows into the burette 22. Thereafter, the fluid flows into drip chamber 50 through its inlet 18. Typically, as the fluid enters drip chamber 50 from inlet 18, it forms droplets that fall from inlet 18 into drip chamber 50.
The fluid filter member 54 positioned within the drip chamber 50 is a filter provided with a hydrophilic filter element. Such hydrophilic filter elements have a pore size ranging from about 0.1 urn to about 14 urn; and hydrophilic surface characteristics such that the filter element is wetted by liquid. Such hydrophilic filter elements are capable of passing therethrough liquid while simultaneously blocking air, provided that the filter element has been wetted with liquid.
The fluid filter member 54 is formed of a generally cylindrical housing 52 whose exterior dimensions correspond to the internal diameter of the drip chamber 50 whereby the filter member 54 is capable of establishing a sealing relationship with the interior walls 26 of the drip chamber 50. For example, the fluid filter member 54 can simply be press-fitted into the drip chamber 50 or, alternatively, the filter can be bonded to the drip chamber 50 to establish a sealing relationship with the drip chamber 50.
An additive set of any type can be utilized and can be filled with the desired drug and its needle associated therewith can be inserted into the integrated injection site 56 provided on the burette 22. It should be appreciated that if desired the cap attached to the tube member connected from the outlet 20 of the injection port can

be removed and a Luer lock or Luer Slip or Rotating Luer lock can be directly mounted thereon. Further, means such as a hanger 76 are provided integrally with the fluid administration set 10 to mount the system fixedly or removably on a hook, pole facilitating its connection with the IV fluid source/bag.
From the foregoing it can be seen that there has been provided a fluid administration set 10 which is of a universal type and which can be utilized without any danger of injecting air into the patient. Further, it can be utilized as a Y-infusion set, a drug injection set. Patient safety will not be comprised because particulates created by injectibles, drug additives piercing the I.V. bottle, in manufactured solutions and the like will be removed by the filter used in the invention. Any air in the solution will be filtered by the filter assembly which acts as a bacteria retentive filter.
Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof.
Thus, from the foregoing description, it will be apparent to one of ordinary skill in the art that many changes and modifications can be made thereto without departing from the spirit or scope of the invention as set forth herein. Accordingly, it is not intended that the scope of the foregoing description be limited to the exact description set forth above, but rather that such description be construed as encompassing all of the features of patentable novelty that reside in the present invention, including all the features and embodiments that would be treated as equivalents thereof by those skilled in the relevant art.

WE CLAIM:
1. A fluid administration set (10) for controlling the flow of fluid, the fluid administration set (10) connected between an IV fluid source and a patient, the said fluid administration set (10) comprising:
a spike connector (12) for coupling to the said IV fluid source;
an inlet tube member (14) coupled to said spike connector (12) connected to the main inlet (18) of a burette (22) defining a chamber (24); the said chamber (24) connected in line with the said tube member (14) to accumulate medical fluid; the said chamber (24) comprising:
an upper end (28) forming the top cap (64) having an inlet port (32);
a lower end (30) forming the bottom cap (66) having an outlet port (34);
a side wall (26) connecting and disposed between the said upper end (28) and to the said lower end (30);
a valve seat (44) mounted in the lower end (30) at the outlet port (34) projecting into the said chamber (24), the said outlet port (34) connected to a drip chamber (50) extending from the bottom thereof and in series with the flow line, the said drip chamber (50) comprising:
an elongated transparent hollow housing (52) defining an inlet (18) at one end thereof and an outlet (20) at the other end,
fluid filter member (54) positioned adjacent the said outlet (20), said fluid filter member (54) defining a pore size sufficient to permit the passage of liquid and to prevent the passage of air, when wetted, under normal conditions of use,
the said outlet (20) connected to an outlet tube member (16); and
a shut-off valve (36) positioned in the said burette chamber (24), the said valve (36) formed such that it floats in the medical fluid accumulated in the said burette chamber (24), the floating disk member comprising:
an upper surface (60), a lower surface (62), and a predetermined amount of buoyancy, the shut-off valve (36) adapted to provide fluid passing from the inlet (18) into the drip chamber (50) while permitting the passage of fluid from the upper surface (60) of the shut-off valve (36) to the lower surface (62) of the shut off-valve (36); and the said valve (36) being configured to be accommodated and

provided support onto the said seat (44) when there is less than a predetermined amount of fluid in the burette chamber (24), the said valve (36) and the said seat (44) forming an air tight seal between the burette chamber (24) and the outlet (20) of the burette (22) to prevent the passage of air into the outlet (20) of the burette (22) when there is less than a predetermined amount of fluid in the burette chamber (24); the said seat (44) being configured as such to allow the buoyancy of the said valve (36) to cause separation between the valve (36) and the seat (44) when there is more than a predetermined amount of fluid in the burette chamber (24) to allow the fluid to flow from the burette chamber (24) into the outlet (20) of the burette (22) and through the said burette chamber (24) to the patient.
2. The fluid administration set (10) as claimed in claim 1, wherein the said shut-off valve (36) comprises an upper ring (38) and an inner ring (40), both of the said rings (38, 40) being provided with an outer circumferential rim and at least two projections 70 configured at the lower surfaces (62) of the said rings (38, 40).
3. The fluid administration set (10) as claimed in claim 1; wherein the said seat (44) provided with a drainage line (46) defining a bore (48) being positioned between the outlet (20) of the said burette (22) and the said drip chamber (50).
4. The fluid administration set (10) as claimed in claim 3, wherein the said drainage line (46) is provided with a circumferential contact surface configured to provide an airtight seal when positioned in contact with the said shut off valve (36).
5. The fluid administration set (10) as claimed in claim 1, wherein the the lower surface (62) of the said shut off valve (36) includes plurality of projections.
6. The fluid administration set (10) as claimed in claim 1, wherein the said fluid filter member (54) positioned generally coaxially with the housing (52) of the said drip chamber (50) and spaced from the walls (26) thereof, whereby the medical fluid passing through said filter member (54) enters into the outlet (20) and thereafter filtered fluid passes through said outlet port (34).

7. The fluid administration set (10) as claimed in claim 1, wherein the said
outlet tube member (16) is connected to an injection site having a self sealing "Y"
injection port (56), the said outlet tube member (16) provided with a roller clamp
(58) and connected from the outlet (20) of injection site to a conventional needle
adapter (78).
8. The fluid administration set (10) as claimed in claim 1, wherein the said burette (22) is provided with calibrated measured volume chamber (24) with bold marking scale (74).